Patterns of Use and Outcomes in Patients Treated with Etravirine in the HIV Research Network

This observational analysis examined the clinical outcomes of patients receiving etravirine-(ETR-) based therapy, particularly with protease inhibitors (PIs) other than darunavir (DRV) and with raltegravir (RAL). Data included treatment-experienced adults in the HIV Research Network who began ETR-containing antiretroviral regimens in 2008–2010. The primary objective was to assess 6-month outcomes (durability, i.e., still on an ETR-containing regimen; change in CD4+ cell count and HIV-1 RNA <400？copies/mL). The cohort included 587 patients receiving ETR; 42% of ETR use was in patients not on DRV/ritonavir (r). Patients receiving ETR plus DRV/r had longer durability versus those on ETR plus a PI other than DRV/r at months 6 (91.2% versus 85.5%) and 12 (77.4% versus 65.2%), respectively. Patients on regimens with a PI other than DRV/r were the least likely to be receiving ETR at month 6 (85.5%) versus patients on other ETR-based regimens. Patients on regimens without a PI and without RAL had lower virologic suppression (month 6, 54.2%; month 12, 63.2%) versus patients on other ETR-based regimens. In a clinical care, nontrial setting, ETR was used in regimens without DRV/r. In this population, the 6-month response rates were similar and durable across all regimens, except when ETR was used without RAL and without a PI. 1. Introduction Aside from registrational trial data, there is limited information on the utilization and clinical outcomes of patients treated with etravirine-(ETR-) based therapy. To date, ETR has demonstrated high efficacy rates, as well as good tolerability and safety profiles [1, 2]. However, in most studies of ETR, including the Phase III trials, all patients also received darunavir/ritonavir (DRV/r). In the DUET 1 and DUET 2 trials, for example, 61% of patients receiving ETR 200？mg twice daily (bid) plus a background regimen that included DRV/r 600/100？mg bid achieved HIV-1 RNA <50 copies/mL at 48 weeks, compared with 40% of patients receiving placebo plus a background regimen that included DRV/r 600/100？mg bid [2]. Interestingly, in the GRACE (Gender, Race, And Clinical Experience) trial, which investigated the efficacy and safety of DRV/r plus an optimized background regimen that could include ETR in treatment-experienced patients, ETR use was associated with higher virologic response rates [3]. Despite encouraging data on the use of ETR plus DRV/r, limited data exist on the use of ETR with protease inhibitors (PIs) other than DRV/r, and with novel agents like raltegravir (RAL) [1, 4–6]. The few data that do exist are promising. The